Patients undergoing surgery deserve and require the utmost care and safety, particularly in preventing post-surgery infections. However, concerns have been raised about the use of Bair Hugger warming blankets and their potential correlation with deep joint infections, leading to long-term damage. Bair Hugger warming blankets were initially introduced in the late 1980s and became widely used in hospitals worldwide. However, in 2010, doubts about the device’s effectiveness and its link to infections emerged.
The Bair Hugger Warming Blanket Lawsuits
The Bair Hugger warming blanket, a medical device used during surgery, helps regulate a patient’s body temperature. However, allegations suggest that this blanket may cause deep joint infections and various side effects, including sepsis, pneumonia, and skin infections. Many plaintiffs in the Bair Hugger lawsuits claim to have developed MRSA, an antibiotic-resistant infection transmitted through bodily fluids, contaminated surfaces, or close contact with objects carrying the MRSA organism.
One reason for the scrutiny surrounding Bair Hugger blankets is their use of an additional device that pulls in warm air from the operating room, subsequently heating the blanket.
Potential Risks to Patients
The device prevents hypothermia in patients during surgery, but it may potentially spew contaminants into the surgical incision, increasing the risk of infection. In essence, the blankets could pose more danger than benefits.
Risk during Surgery
The device poses a high risk of deep joint infections during surgery, especially during hip and knee replacement surgeries.
Post-Surgery Infections
After surgery, bacteria can infiltrate the artificial joint during slow growth phases, causing long-term issues and damage that often necessitate corrective surgery. Treating these adverse events involves a combination of surgeries (such as explantation and revision surgeries) and a lengthy course of antibiotics. Infections can also persist for weeks or months.
FDA Approval of Bair Hugger
The FDA approved Bair Hugger as a surgical warming device in 1987. It consists of a disposable blanket and a warming unit that blows hot air through it, making it a single-use device.
The Initial Lawsuit Filed
In 2013, patient Tommy Walton filed the first Bair Hugger lawsuit, seeking $1 million. Walton claimed that he underwent a revision total knee replacement surgery in December 2011 and attributed the Methicillin-resistant Staphylococcus aureus (MRSA) infection, which resulted in additional surgeries, to the use of the Bair Hugger device. Walton argued that the device disrupted the sterile environment and facilitated the spread of bacteria.
Surge of Additional Lawsuits
From 2013 to 2015, the Bair Hugger device resulted in numerous lawsuits in federal courts. More than a dozen patients filed suits, alleging injuries and complications. These lawsuits were filed in different states, including Texas, Minnesota, and California.
Creation of Multidistrict Litigation (MDL)
In December 2015, a federal panel consolidated the first 14 Bair Hugger lawsuits into a multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota under the oversight of Judge Joan Ericksen. An MDL is a federal lawsuit that combines similar cases and streamlines pretrial proceedings.
Selection of Bellwether Cases
In August 2017, the MDL judge selected five cases for bellwether trials to test the strength of both plaintiff and defense arguments before actual trials began. These representative cases, chosen from the broader litigation, aim to provide parties with insight into how other juries may interpret the evidence in similar cases.
3M’s Win in the First Bellwether Trial
In May 2018, the manufacturer 3M emerged victorious in the first bellwether trial held in Minneapolis. The plaintiff had accused the Bair Hugger device of causing a deep joint infection during hip replacement surgery, and claimed that 3M had failed to provide adequate warnings about its risks. However, the jury disagreed, finding that the device was neither defective nor unreasonably dangerous.
Number of Bair Hugger Lawsuits Filed
According to reports in April 2019, individuals had filed 5,659 Bair Hugger lawsuits, with 5,036 still pending in the MDL. The manufacturers persistently denied that their device was the cause of any infections in surgical patients.
Dismissal of Remaining Cases by Judge Ericksen
In August 2019, U.S. District Judge Joan Ericksen dismissed all remaining cases in the MDL. She ruled that the plaintiffs’ experts’ scientific methodology and studies were unreliable and further stated that they failed to provide any evidence proving the Bair Hugger device caused the plaintiffs’ infections.
Reopening of the Case in 2020
However, in 2020, the case was reopened due to newly discovered evidence that shed light on 3M, the manufacturer, having known about the defects in the device since its conception.
Consolidation of Lawsuits into Multidistrict Litigation (MDL)
By 2023, most of these lawsuits have consolidated into multidistrict litigation (MDL) proceedings. This consolidation groups all cases together and assigns a single judge, streamlining the legal process and ensuring consistent rulings. The first MDL case went to trial in early 2022, and more trials are expected in the future.
Increase in Lawsuits
Lawsuits against Bair Hugger have significantly increased in recent years. As of August 16, 2023, the MDL reported 5,250 lawsuits against Bair Hugger. The number is expected to continue to rise as more patients become aware of potential risks associated with these blankets. Patients who encounter adverse effects after surgery can consult a surgeon to assess the involvement of the Bair Hugger blanket in the development of the infection. Patients may qualify to join existing lawsuits or file their own lawsuit against the manufacturer.
Recall Status: No Recall by FDA or 3M
Despite the mounting lawsuits against the Bair Hugger, the device has not been recalled. The US Food and Drug Administration (FDA) has not issued a recall, nor has 3M Company voluntarily recalled the product. The FDA stated that it is aware of the concerns about the Bair Hugger and is closely monitoring the situation.
Although some hospitals and medical professionals have chosen to discontinue using the device due to the lawsuits and raised safety concerns, the Bair Hugger is still in use today. Critics argue that Bair Hugger’s design makes it difficult to prevent the spread of bacteria and other contaminants, putting patients at risk of developing serious infections.
How Gallon, Takacs & Boissoneault Can Help You
If you underwent surgery using a Bair Hugger warming blanket and experienced health complications as a result, you may have the right to join the MDL case. At Gallon, Takacs & Boisoneault law firm, we understand the traumatic and costly impact of these injuries, which is why we offer services to support those affected by these complications. Our team of experienced attorneys will assess your case, file your claim, and provide legal representation throughout the process. We have a proven track record in representing clients in complex medical device lawsuits and possess the necessary knowledge and expertise to navigate the legal system on your behalf. So, if you believe that a Bair Hugger warming blanket has caused harm, get in touch with Gallon, Takacs & Boisoneault law firm today at 419-843-6663 or online to schedule your initial consultation.
